20 results
·
34ms
·
Sources: EU EUDAMED, US FDA
MULTI JOINT WEIGHT SYSTEM MODEL #940-100
FDA 510(k)
FDA Class 2
·Physical Medicine
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123281·K-WIRE - DOUBLE TROCAR 2.0mm DIA x 150mm
V-HYADASE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
PHT-6500; PHT-60CFO; PAX-I3D
FDA 510(k)
FDA Class 2
·Radiology
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 7, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 10, 2020
FLEXTEND
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code DTB·January 18, 2013
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code JJE·December 13, 2010
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 9, 2014
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·April 3, 2018
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 29, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 20, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 16, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·July 24, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 18, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·September 24, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·October 23, 2019
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·December 4, 2017
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·June 18, 2020
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offered for sale in the US: EVT808015, EVT808025, EVT812015, and EVT812025 Sterile EO. Product Usage: Intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
FDA Enforcement
Class I
·Terminated·Covidien·February 11, 2015